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Monday, June 27 • 10:45am - 12:00pm
#123: Global Clinical Trials: Innovative Approaches to Clinical Trials in Japan, India, and Latin America

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Limited Capacity seats available

Component Type: Symposium
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

In this symposium, the presenters are examining various innovative approaches to and requirements for conducting clinical trials in Japan, India, and Latin America, as well as how their respective regulatory environments have contributed to fostering innovation, product development, and clinical research.

Learning Objectives

Discuss the requirements for conducting clinical trials in Japan, India and Latin America; Share insights into innovative regulatory approaches that could impact clinical studies in these regions; Describe factors one needs to consider when conducting ethno-bridging studies outside the United States.

Chair

Larry A. Blankstein, PhD

Speaker

Issues and Solutions When Conducting Complex Caucasian Clinical Studies in Japan
Andrew Melli

Clinical Trials in India: An Update on Current Status
Charu Gautam, MD

Clinical Research in Latin America: Trends, Challenges and New Opportunities
Maria João Queiroz, MD



Chair
avatar for Larry Blankstein

Larry Blankstein

Consultant, Clinical Development, Blankstein Consulting Group
Dr. Larry Blankstein is an independent Senior Consultant to the Pharmaceutical and Biotechnology industry. He has over twenty-two years experience in drug development strategy, clinical operations and mergers and acquisitions. He received his Ph.D. degree in Biology from Wesleyan University in Middletown, CT. His industry drug development experience was at Quintiles, Seragen and Genzyme.

Speakers
avatar for Charu Gautam

Charu Gautam

Director, Global Clinical Operations, Cliantha Research Ltd
Charu Gautam is a Pharmaceutical Physician with 17 years experience in research and academics. Been associated with leading companies in India to lead the clinical operations and Medical teams. Qualified as MBBS, MD followed by a board certification , she is also a lead faculty at various GCP workshops and conferences. Experienced with Phase I and Phase II /III studies in Oncology, Dermatology, GI, Psychiatry and been part of team conducting... Read More →
avatar for Andrew Melli

Andrew Melli

Senior Manager, SOUSEIKAI Global Clinical Research Center
Andrew Melli is the Senior Manager of Scientific Affairs and Foreign Relations at SOUSEIKAI Global Clinical Research Center, serving as both PR liaison for international business development, as well as an active supporting member of the clinical trial team. It is his hope to bridge the information gap for those interested in next-level clinical trials and a mature Japanese market, complimented by a revamped Japanese regulatory structure on par... Read More →
avatar for Maria João Queiroz

Maria João Queiroz

Chief Executive Officer, Eurotrials Scientific Consultants
More than two decades at executive leadership positions in the pharmaceutical industry, Founding Member & CEO at Eurotrials, a CRO in Europe and Latin America. With a Degree in Medicine, specialization in Immunohematology and a post-graduation in Pharmaceutical Medicine. Has active participation in Health Cluster Portugal, CLC Council at DIA, Advisory Council of School of Health Science at University of Minho and in Academic Clinical Research... Read More →


Monday June 27, 2016 10:45am - 12:00pm
113B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA